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MSD Ovipast Plus Protection Against Pasteurella

  • 100ml Bottle £38.13
  • 500ml Bottle £168.71

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Description

Vaccine with iron regulated proteins for improved protection against pasteurella. A multi-component
pasteurella haemolytica vaccine containing the same pasteurella antigens as Heptavac P and
Ovivac P. Dosage 2ml. Refrigerated Product. POM-VPS

Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication.

Introduction

MSD-AH
Company name: MSD Animal Health
Address: Walton Manor
Walton
Milton Keynes
MK7 7AJ
Telephone: 01908 685685 (Customer Support Centre)
Fax: 01908 685555
Email: vet-support.uk@merck.com
Website: www.msd-animal-health.co.uk
 

Presentation

Per 1 ml:
5 x 108 formalin killed cells each of Mannheimia haemolytica strains A1 (S1006/77), A2 (S1126/92), A6 (S1084/81), A7 (S1078/81), A9 (S994/77) and Pasteurella trehalosi strains T3 (S1109/84), T4 (S1085/81), T10 (S1075/81), T15 (S1105/84), Alhydrogel, Thiomersal.
 

Uses

For the active immunisation of sheep as an aid in the control of pasteurellosis caused by M. haemolytica and P. trehalosi. The vaccine may be used as an aid in the control of pneumonic pasteurellosis in sheep of all ages from a minimum age of 3 weeks and in the control of systemic pasteurellosis in weaned fattening and breeding sheep.
The vaccine may be used in pregnant ewes as an aid in the control of pasteurellosis in their lambs provided that the lambs receive sufficient immune colostrum during the first 1-2 days of life.
 

Dosage and administration

Subcutaneous injection in the lateral side of the upper neck.
All sheep not previously vaccinated with Ovipast Plus must receive two injections, each of 2 ml, separated by an interval of 4-6 weeks. Thereafter they must receive booster injections at intervals of not more than 12 months. In adult breeding ewes these yearly booster injections should be given during the pre-lambing period, 4-6 weeks pre-lambing, as an aid in the control of pasteurellosis in their lambs.
On farms where the incidence of pasteurellosis is high, a supplementary booster vaccination with Ovipast Plus may be required 2-3 weeks prior to expected seasonal outbreaks.
Advice on correct administration
When handling sheep, stress should be avoided, particularly during the later stages of pregnancy when there is a risk of inducing metabolic disorders which may lead to abortion.
The vaccine bottle must be shaken well before use. Do not freeze.
Use sterile syringes and needles. No alcohol or other disinfectants should be used for sterilisation.
The use of an automatic vaccinator is recommended. Since the bottle is non-collapsible, a vaccinator with a draw-off spike or similar device must be used. The instructions supplied with such equipment should be noted and care should be taken to ensure the delivery of the full dose, particularly with the final few doses from the bottle.
No information is available on the effects of the concurrent use of this vaccine with any other. It is therefore suggested that no other vaccine should be administered within 14 days before or after vaccination with the product. If in doubt, advice should be sought from a veterinary surgeon.
 

Contra-indications, warnings, etc

The vaccine contains an adjuvant and, as with most adjuvanted vaccines, immunisation may result in temporary swellings at the injection site. Typically, these swellings may be warm when compared with the surrounding area for up to 14 days after vaccination. Safety studies in lambs have shown that the swellings did not appear to inconvenience the animals or hinder neck movement.
As with all vaccines, occasional hypersensitivity reactions may occur.
The nutritional and metabolic status of pregnant ewes is extremely important at the time of vaccination. If in doubt, advice should be sought from a veterinary surgeon.
Withdrawal period
Zero days.
For animal treatment only. Keep out of reach and sight of children.
 

Pharmaceutical precautions

Store between +2°C to +8°C. Do not freeze.
Once broached use within 10 hours.
Partly used and empty packs, syringes and needles must be disposed of in accordance with the requirements for clinical waste.
 

Legal category

POM-VPS
 

Packaging Quantities

Bottles containing 100 or 500 ml. Not all pack sizes may be marketed.
 

Further information

In any group of animals, a small number of individuals may fail to respond to vaccination as a result of immunological incompetence. Satisfactory immune responses will only be attained in healthy animals, thus it is important to avoid vaccination of animals which have intercurrent infection or metabolic disorder. As with most killed vaccines, significant levels of immunity cannot be expected until two weeks after the second dose vaccine in the primary vaccination course.
Evidence of efficacy of the Pasteurella component of Heptavac P Plus was generated in an experimental infection model and it is not possible to provide duration of immunity information using this system. There are reports that active immunity will last for up to one year and that passive immunity will persist for up to 4 weeks after birth in lambs from ewes vaccinated with conventional Pasteurella vaccines.
Heptavac P Plus, Ovivac P Plus and Ovipast Plus have been developed following research and development which resulted in the application of new ‘IRP’ technology for the manufacture of the Pasteurella components of these vaccines. The inclusion of these IRP components should provide enhanced efficacy and cross protection e.g. protection against serotype A12, which is not included in the vaccine, has been demonstrated. Studies on the response of sheep to these vaccines show that two injections separated by an interval of 4-6 weeks are required to gain the full benefit of the ‘IRP’.
 

Marketing authorisation number

Vm 01708/4401.
 

Qualitative and quantitative composition

Active substances:

Formalin killed cells of the following Mannheimia haemolytica strains:

A1 (S1006/77

5 x 108 cells*

A2 (S1126/92)

5 x 108 cells*

A6 (S1084/81)

5 x 108 cells*

A7 (S1078/81)

5 x 108 cells*

A9 (S994/77)

5 x 108 cells*

* Including at least 22% OD reduction, measuring transferring binding inhibition in rabbit sera.

Formalin killed cells of the following Pasteurella trehalosi strains:

T3 (S1109/84)

5 x 108 cells**

T4 (S1085/81)

5 x 108 cells**

T10 (S1075/81)

5 x 108 cells**

T15 (S1105/84)

5 x 108 cells**

** Including a significant (p<0.05) OD increase, determining antibody response in rabbit sera.

Adjuvant: Aluminium hydroxide gel 250 mg.

Excipient:

Preservative: Thiomersal 0.13 mg.

For a full list of excipients, see section “Pharmaceutical particulars”.

Pharmaceutical form

Suspension for injection.

Clinical particulars

Target species

Sheep.

Indications for use

For the active immunisation of sheep as an aid in the control of pasteurellosis caused by M.haemolytica and P.trehalosi. The vaccine maybe used as an aid in the control of pneumonic pasteurellosis in sheep of all ages from a minimum age of 3 weeks and in the control of systemic pasteurellosis in weaned fattening and breeding sheep.

The vaccine may be used in pregnant ewes as an aid in the control of pasteurellosis in their lambs provided that the lambs receive sufficient immune colostrum during the first 1-2 days of life.

Contra-indications

None.

Special warnings for each target species

The nutritional and metabolic status of pregnant ewes is extremely important at the time of vaccination. If in doubt, advice should be sought from a veterinary surgeon.

The vaccine contains an adjuvant and, as with most adjuvanted vaccines, may result in small transient injection site reactions possibly lasting for up to 3 ‑ 4 months after vaccination.

Special precautions for use

In any group of animals, a small number of individuals may fail to respond to vaccination as a result of immunological incompetence. Satisfactory immune responses will only be attained in healthy animals, thus it is important to avoid vaccination of animals which have intercurrent infection or metabolic disorder. As with most killed vaccines, significant levels of immunity cannot be expected until two weeks after the second dose vaccine in the primary vaccination course.

When handling sheep, stress should be avoided, particularly during the later stages of pregnancy when there is a risk of inducing metabolic disorders which may lead to abortion.

The vaccine bottle must be shaken well before use. Do not freeze. Syringes and needles must be from gamma-irradiated packs or freshly sterilised by boiling for a least 20 minutes. No alcohol or other disinfectants should be used for sterilisation.

The use of an automatic vaccinator is recommended. Since the bottle is non-collapsible, a vaccinator with a vented draw-off spike or similar device must be used. The instructions supplied with such equipment should be noted and care should be taken to ensure the delivery of the full dose, particularly with the final few doses from the bottle.

Partly used packs must be destroyed at the end of a day's operations, as re‑puncture of the rubber cap could cause contamination of the remaining contents.

Adverse reactions

The vaccine contains an adjuvant and, as with most adjuvanted vaccines, immunisation may result in temporary swellings at the injection site. Typically, these swellings may be warm when compared to the surrounding area for up to 14 days after vaccination. Safety studies in lambs have shown that the swellings did not appear to inconvenience the animals or hinder neck movement. As with all vaccines, occasional hypersensitivity reactions may occur.

Use during pregnancy, lactation or lay

Ewes may be vaccinated during pregnancy as an aid in the control of pasteurellosis in their lambs provided that the lambs receive sufficient immune colostrum during the first 1-2 days of life.

Interactions

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.

Amounts to be administered and administration route

The vaccine should be administered by subcutaneous injection in the lateral side of the upper neck observing aseptic precautions. All sheep not previously vaccinated with Ovipast Plus must receive two injections, each of 2 ml, separated by an interval of 4-6 weeks. Thereafter they must receive booster injections at intervals of not more than 12 months. In adult breeding ewes these yearly booster injections should be given during the pre-lambing period, 4‑6 weeks pre-lambing, as an aid in the control of pasteurellosis in their lambs.

On farms where the incidence of pasteurellosis is high, a supplementary booster vaccination with Ovipast Plus may be required 2-3 weeks prior to expected seasonal outbreaks.

The use of automatic vaccination equipment is recommended. The vaccine may be administered using a sterile needle and syringe, providing a fresh sterile needle is used each time the rubber cap is punctured, to avoid contamination of the remaining contents.

Evidence of efficacy of the Pasteurella/Mannheimia component of Heptavac P Plus was generated in an experimental infection model and it is not possible to provide duration of immunity information using this system. There are reports that active immunity will last for up to one year and that passive immunity will persist for up to 4 weeks after birth in lambs from ewes vaccinated with conventional Pasteurella vaccines.

Heptavac P Plus, Ovivac P Plus and Ovipast Plus have been developed following research and development which resulted in the application of new ‘IRP’ technology for the manufacture of the Pasteurella/Mannheimia components of these vaccines. The inclusion of these IRP components should provide enhanced efficacy and cross protection e.g. protection against serotype A12, which is not included in the vaccine, has been demonstrated. Studies on the response of sheep to these vaccines show that two injections separated by an interval of 4-6 weeks are required to gain the full benefit of the ‘IRP’.

Overdose

Accidental overdosage is unlikely to cause any reaction other than described in Section "Adverse reactions". No adverse local reactions were noted in overdose studies performed in pregnant ewes and lambs. A mild febrile response was noticed in some lambs that received an overdose.

Withdrawal periods

Zero days.

Pharmacological particulars

Immunological properties

To stimulate active immunity against pasteurellosis in sheep.

ATC vet code: QI04AB02

Pharmaceutical particulars

Excipients

Aluminium hydroxide gel and Thiomersal.

Major incompatibilities

Do not mix with any other veterinary medicinal product.

Shelf life

3 years.

Once opened, use of the vaccine should be completed within 10 hours. Partially used containers must be discarded at the end of each day's operations.

Special precautions for storage

Store at +2°C to +8°C in the dark. Do not freeze. Use before the expiry date printed on the pack.

Immediate packaging

The containers are being made of low density polyethylene of 100 ml and 500 ml volume.

Disposal

Partly used and empty packs, syringes and needles must be disposed of in accordance with the requirements for clinical waste.

Marketing Authorisation Holder (if different from distributor)

Marketing authorisation number

Vm 01708/4401.

Date of the first authorisation or date of renewal

22 February 2006.

Date of revision of the text

April 2012.

Any other information

Nil

Legal category

POM-VPS

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